If you work in the life sciences sector, you must validate your computerized systems. Call us and we will help you.

In Asfalia we perform audits related with the computer systems, taking into account the regulations and the sector

We approach the process as an opportunity of improvement

According to the ISO (International Organization for Standardization), the audit is a systematic, independent and documented process to obtain objective evidence and evaluate it objectively in order to determine the degree to which the audit criteria are met and whose purpose is to diagnose and identify which activities are performed as expected, which are not, and those that can be improved. In the regulated sector, its criteria are usually compliance with regulations, both internal and external, and are applicable to computer systems, the quality system, the personnel of a department or suppliers.

Reasons to conduct an audit

The reasons for conducting an audit include: periodic reviews of the validation status of the system, the acquisition of a new computer system or the opening to international markets that entail the obligation to comply with new regulations. In all these cases, the audit reports are a very useful tool for the company when selecting a system, a supplier or establishing a plan for improvements or corrective actions. If you are awaiting a periodic review, want to ensure that a system complies with the regulations applicable to the regulated sector, the degree of maturity of a supplier or you must execute the action plan of a third-party audit, do not hesitate to contact us and we will be happy to help you.